A Comparative Study on Trans-umbilical Single-port Laparoscopic Extra-peritoneal Approach Versus Conventional Repair for Inguinal Hernia in Children

Inguinal hernia is a common disease in children. Treatment of this disease by laparoscopic high ligation of the hernia sac has been accepted by domestic and foreign scholars. Since laparoscopic inguinal hernia was introduced in 1990,it has now become the most commonly performed hernia repair in children. The conventional approach this is done with2small trocars to 1trocar . however the wound complications of infection and pain and the recurrent rate have not been resolved. The aim of the study was to described a new way of extra-peritoneal high ligation of hernia sac. This method combines the single-port laparoscopic could eliminated rate of wound complications and recurrence in inguinal hernia repair in children. The investigators hoped that this study will prove that the extra-peritoneal single-port laparoscopic repair is at least a s effective and efficient as the conventional technique in the cure of inguinal hernia and may results in lower recurrence and reduce incidence of wound complications.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia,Laparoscopy,Extra-peritoneal
• Intervention / Treatment: Procedure: extra-peritoneal high ligation of hernia; Procedure: intraabdominal high ligation of hernia

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Recruiting
      • Affiliated Hospital of Zunyi Medical College
      • Principal Investigator: Fan Zhang, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

All patients between 6 months and 13 years undergoing trans-umbilical single-port laparoscopic approach repair for inguinal hernia at our institution. half of patients undergoing extra-peritoneal andthe others undergoing intraabdominal.

Description

Inclusion Criteria:

unilateral inguinal herina age between 6 months and 13 years no history of abdominal or inguinal operations of male patients ,only those with completely descended testes were included

Exclusion Criteria:

the bilateral heina the recurrence herina

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
extra-peritoneal high ligation of hernia; the 150 patients were subjected trans-umbilical single-port laparoscopic extra-peritoneal approach repair for inguinal hernia	Procedure: extra-peritoneal high ligation of hernia
intraabdominal high ligation of hernia; the 150 patients were subjected trans-umbilical single-port laparoscopic intraabdominal approach repair for inguinal hernia	Procedure: intraabdominal high ligation of hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion to intraabdominal high ligation of inguinal hernia	this study is to determine whether extra-peritoneal single-port laparoscopic repair for inguinal hernia in children is superior to conventional repair approaches.	during operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operating time	this assess the time taken to perform the operation and is defined as time from initial skin to complete wound closure	during operation
length of hospital time	this assess how long patient stays in hospital	day procedure or overnight stay
post operative pain scores	this utlizes the CHEOPS pain score4-7,day 1 and day 7 after surgy	preop, day one and day 7 postop
recurrence of inguinal herina	patients will be assessed at 1 week,6 week and one year to detect presence of recurrence of inguinal herina	1 year
post-operation complications including wound infection,stitch abscess, spermatic cord injuries,testicular atrophy.	patients will be seen at 1 week,6 week to assess for any peri-operative complications associated with inguinal herina surgery as enumerated above.	6 weeks

Collaborators and Investigators

• Sponsor: zebing Zheng

Publications and helpful links

General Publications

• Jun Z, Juntao G, Shuli L, Li L. A comparative study on trans-umbilical single-port laparoscopic approach versus conventional repair for incarcerated inguinal hernia in children. J Minim Access Surg. 2016 Apr-Jun;12(2):139-42. doi: 10.4103/0972-9941.169953.
• Wolak PK, Patkowski D. Laparoscopic inguinal hernia repair in children using the percutaneous internal ring suturing technique - own experience. Wideochir Inne Tech Maloinwazyjne. 2014 Mar;9(1):53-8. doi: 10.5114/wiitm.2014.40389. Epub 2014 Jan 30.
• Blanco FC, Kane TD. Single-port laparoscopic surgery in children: concept and controversies of the new technique. Minim Invasive Surg. 2012;2012:232347. doi: 10.1155/2012/232347. Epub 2012 Jun 12.
• Lukong CS. Surgical techniques of laparoscopic inguinal hernia repair in childhood: a critical appraisal. J Surg Tech Case Rep. 2012 Jan;4(1):1-5. doi: 10.4103/2006-8808.100343.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 9, 2016

Study Record Updates

• Last Update Posted (Estimate): November 9, 2016
• Last Update Submitted That Met QC Criteria: November 7, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: ZunyiMC